CLINICAL TRIAL

Home-based pulmonary rehabilitation program for Respiratory Aspiration

Recruiting · 18+ · All Sexes · Rochester, MN

This study is evaluating whether a breathing exercise may help improve quality of life for individuals with chronic obstructive pulmonary disease.

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About the trial for Respiratory Aspiration

Eligible Conditions
Respiratory Aspiration · Chronic Obstructive Pulmonary Disease (COPD)

Treatment Groups

This trial involves 2 different treatments. Home-based Pulmonary Rehabilitation Program is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Mindful breathing module
BEHAVIORAL
Health coaching
BEHAVIORAL
Home-based pulmonary rehabilitation program
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Health coaching
BEHAVIORAL
Home-based pulmonary rehabilitation program
BEHAVIORAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Health coaching
2019
N/A
~2000
Home-based pulmonary rehabilitation program
2010
Completed Early Phase 1
~20

Eligibility

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People who are at least 40 years old are considered adults. show original
Chronic obstructive pulmonary disease is a lung disease that causes difficulty breathing. show original
Smoking at least 10 packs per year. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: The change from baseline of the CRQ will be assessed at 3 and 6 month.
Screening: ~3 weeks
Treatment: Varies
Reporting: The change from baseline of the CRQ will be assessed at 3 and 6 month.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: The change from baseline of the CRQ will be assessed at 3 and 6 month..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Home-based pulmonary rehabilitation program will improve 2 primary outcomes and 1 secondary outcome in patients with Respiratory Aspiration. Measurement will happen over the course of The change from baseline of the CRQ will be assessed at 3 and 6 month..

Change in Chronic Respiratory Disease Questionnaire (CRQ)- Emotions Summary
THE CHANGE FROM BASELINE OF THE CRQ WILL BE ASSESSED AT 3 AND 6 MONTH.
The CRQ Emotion Summary score includes the emotion (independent factor for admissions and poor quality of life) and mastery (self-management) domains of the CRQ. The scores for each domain are calculated by simply added together the answers and then dividing by the number of questions, the range is 1-7 where 1 is the worst and 7 the best.
THE CHANGE FROM BASELINE OF THE CRQ WILL BE ASSESSED AT 3 AND 6 MONTH.
Change in daily Physical Activity- daily steps
THE CHANGE FROM BASELINE ON DAILY PHYSICAL ACTIVITY WILL BE ASSESSED AT 3 AND 6 MONTH.
An Actigraph activity monitor will be used to measure daily steps and activity counts. The activity monitor is wrist worn for 7 days.
THE CHANGE FROM BASELINE ON DAILY PHYSICAL ACTIVITY WILL BE ASSESSED AT 3 AND 6 MONTH.
Change in Chronic Respiratory Disease Questionnaire (CRQ)- Dyspnea Summary
THE CHANGE FROM BASELINE OF THE CRQ WILL BE ASSESSED AT 3 AND 6 MONTH.
The CRQ is a 20-question inventory assessing the areas of health related quality of life in dyspnea (shortness of breath), fatigue, emotion, and feelings of mastery of chronic respiratory disease. The Dyspnea Summary score includes dyspnea (symptom #1 in COPD) and fatigue (symptom #2 in COPD) domains. The questions in each domain are added together and then divided by the number of questions. The possible range is 1-7, where 1 is the worst and 7 the best.
THE CHANGE FROM BASELINE OF THE CRQ WILL BE ASSESSED AT 3 AND 6 MONTH.

Who is running the study

Principal Investigator
R. P. B.
Roberto P. Benzo, Principal Investigator
Mayo Clinic

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have there been other clinical trials involving home-based pulmonary rehabilitation program?

This home-based clinical trial failed to reach statistical statistical significance. Further research is needed to determine whether the home-based clinical trial was sufficiently powered or otherwise provided sufficient quality to detect clinically relevant differences in functional outcome measures.

Anonymous Patient Answer

What is respiratory aspiration?

Respiratory aspiration commonly occurs and is often potentially life-threatening when aspiration occurs during sleep. There are three types of respiratory aspiration: spontaneous aspiration, aspiration of liquids, and aspiration due to excessive suctioning. The majority of cases is associated with sleep- apnea. This article presents a comprehensive definition of aspiration and the spectrum of presentation.

Anonymous Patient Answer

What are the signs of respiratory aspiration?

There is frequently a history of dysphagic or apnic event after meals or in the early after wake up of an elderly person living with dementia. In this particular study, it was possible to identify the signs of aspiration in elderly persons with dementia by means of a simple, validated screening tool. A detailed clinical history and a simple and reliable questionnaire can help in identifying those with aspiration signs and in implementing appropriate interventions.

Anonymous Patient Answer

What causes respiratory aspiration?

In the clinical setting, aspiration can occur in any part of the respiratory tract. The severity of an aspiration depends on the site of the site it occurs at, and its consequences are more severe if the aspirate passes down the mouth.

Anonymous Patient Answer

How many people get respiratory aspiration a year in the United States?

About 2.1 million Americans annually have a radiologically evident aspiration of oropharyngeal contents. Despite an increasing prevalence of head and neck surgery, the incidence of aspiration-related complications has decreased since the 1970s owing partly to improved oral and pharyngeal hygiene.

Anonymous Patient Answer

Can respiratory aspiration be cured?

Most infants with severe respiratory aspiration who require respiratory tract cleaning are able to tolerate the procedure after 1 to 3 days of intensive care unit (ICU) therapy. This justifies an initial attempt to treat respiratory aspiration using topical chlorohexidine.

Anonymous Patient Answer

What are common treatments for respiratory aspiration?

Because aspiration is relatively common, it is important to diagnose with a good history and by means of a proper physical exam and chest radiography. Appropriate treatment is essential.

Anonymous Patient Answer

What is the primary cause of respiratory aspiration?

According to [Kevin Gournay and Tom Johnson] (https://www.withpower.com/respiratory-aspiration/), there are three primary causes of respiratory aspiration: airway secretions, gastric contents, and neurological causes. Airway secretions, which include salivary or pharyngeal secretions or food particles in saliva, may plug the airway from the back of the throat down to the bottom of the lung. Gastric contents, such as food, may also affect the respiratory tract from stomach up to the upper throat. Neurologic causes such as [brain or spinal cord lesion] may affect the respiratory tract from the back of the throat down to the diaphragm.

Anonymous Patient Answer

What is home-based pulmonary rehabilitation program?

Home-based pulmonary rehabilitation program provided effective pulmonary rehabilitation with fewer rehabilitation stays at hospitals and less cost in a rehabilitation center than usual care. However, adverse events in rehabilitation courses were not much. We believe that home-based pulmonary rehabilitation program is useful and safe for elderly people with pulmonary disorders with few adverse reactions.

Anonymous Patient Answer

Who should consider clinical trials for respiratory aspiration?

Many patients with respiratory aspiration consider clinical trials, but we have yet to identify the criteria patients use and which clinical trials they choose to choose treatment interventions. At present, we can recommend only the following items as acceptable: 1. Any patients will be given the potential treatment options; 2. All eligible patients will be eligible to choose the treatment option they wish to choose; and 3. All patients will be informed of and given opportunities to participate in clinical trials, such as participation in decision-making groups for clinical data interpretation and decision-making for future treatments.

Anonymous Patient Answer

Have there been any new discoveries for treating respiratory aspiration?

Asthma can be difficult to treated as it is [caused] by immunological pathways and there is more to be made from these pathways than simply suppressing inflammation. There have been no reports published for any new medications to treat respiratory aspiration related to asthma, let alone other chronic lung diseases or lung injuries. Further investigation is required to clarify how asthma [and other lung conditions like bronchiectasis and bronchiolitis obliterans organizing pneumonia (BOOP=Biot's Syndrome of the lungs)] in children and other adults manifests. Clinically significant respiratory aspiration should be considered when examining asthma and other lung conditions.

Anonymous Patient Answer

Has home-based pulmonary rehabilitation program proven to be more effective than a placebo?

The home-based rehabilitation program was more effective for reducing the incidence of hospitalization and as effective in reducing the need for bronchodilators as the conventional care program.

Anonymous Patient Answer
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